JPH0392153A - Closure-attaching means for ostomy appliance - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION Field of Industrial Use, Prior Art, and Problems to be Solved by the Invention Cilento et al., U.S. Pat. And in it,
The body side includes a first adhesive member that contacts the skin adjacent to the small hole, a connecting member, and a second adhesive member that has a certain degree of porosity and is thinner and more flexible than the first adhesive member. It is a composite consisting of parts. 2nd above
The adhesive member contacts the skin away from the stoma.

Alexangou U.S. Pat. No. 4,419,100 discloses a two-part aneurysm surgery system in which the body side includes a breathable, water-resistant, microporous lining (3);
It is provided with a resilient sealing ring 32 of a flexible adhesive material capable of sealingly engaging the peristomal portion fixed at zero. Above lining 30
A portion of the sealing ring 32 extends beyond the sealing ring 32 and is coated with a layer of pressure sensitive, microporous adhesive.

Campbell U.S. Patent No. 4,490,145! A component ostomy pouch is disclosed in which the adhesive attachment means is 2 to 3 mils thick.
A ring of non-porous hydrocolloid containing an IO-3O mil adhesive was attached to a tape of IIlils. The tape consists of a microporous adhesive and an air permeable nonwoven backing.

EP 264.299 to Samuelson discloses a hydrocolloid consisting of an adhesive skin barrier or occlusive pad that can be used as an attachment means for an ostomy bladder. The outer surface of the sealing pad is sloped such that the thickness adjacent its outer edge is not more than about one-fourth the thickness of the non-slope portion.

Means for solving the problem/Action/effect of the invention This invention {
The ostomy device is attached to the user's body.
(appliance). The attachment means is a relatively thick tube adapted to be fixed to the skin around the stoma. an adhesive member and a relatively thin, flexible second adhesive member adapted to be secured to the skin remote from the stoma. Rather than the conventional composite devices described above, both adhesive members are mixtures containing one or more water-soluble or water-swellable hydrocolloids dispersed within polyisobutylene in addition to other optional ingredients. It has a closing adhesive layer created as A backing layer comprising a thin polymeric film or nonwoven material is provided within the second adhesive member, and a thin polymeric film is also provided within the first adhesive member.

The closure attachment means of the present invention can be used as a skin barrier in a two-part ostomy system. In this embodiment, for example, U.S. Pat.
No. 0,363 and U.S. Pat. No. 4,775,3 to Cilento et al.
A body side connection member of the type disclosed in No. 74 is often used so that the ostomy pouch connection member can be connected to the ostomy pouch connection member and disconnected when desired. The flange skirt of the bodyside connecting member can be applied to a thin polymeric backing film over the relatively thick first adhesive member;
The relatively thin flexible second adhesive member can be secured to opposite sides of the flange skirt.

In this embodiment, the backing layer can be either a polymeric film or a nonwoven fabric. Instead, the second
The adhesive member may also be secured directly to the first adhesive member, i.e. directly to the first adhesive layer, with the flange skirt of the connecting member being secured to the thin polymeric film on the second adhesive member. You can also.

The closure attachment means of the present invention may also be used as part of a one-piece surgical bladder.

In this embodiment, the relatively thin second adhesive member can be secured directly to the relatively thick first adhesive member or first adhesive layer, and the thin polymeric backing film of the second adhesive member is It can be secured to the incisional sac in the area around the opening that constitutes the ostium. Alternatively, the thin polymeric film of the relatively thick first adhesive member is not secured to the bladder in a portion around the opening defining the ostium of the bladder. The outer edge of the member can be retained and secured to the ostomy bag.

The relatively thin and flexible second adhesive member is secured to this outer edge portion of the backing film of the first member. In this embodiment, the backing layer can be either a polymeric film or a nonwoven fabric.

The present invention is also directed to an improved method for securing a relatively thick first adhesive member to a relatively thin, flexible second adhesive member. As a result of this method, both adhesive surfaces can be protected before use by a single sheet of release paper. This provides additional convenience to the user when securing the closure attachment means to the perioral area.

The present invention is directed to an adhesive attachment means that can be used as part of a one-piece or two-piece ostomy device. The adhesive attachment means may be attached to the perioral area.
al) a first adhesive member having a first adhesive layer in contact with the skin in a portion immediately adjacent to and surrounding the stoma of the user, known as the stoma, and a second adhesive attached to the skin remote from said stoma; a second adhesive member having a layer.

Unlike conventional adhesive systems, both the first and second adhesive layers of the above described attachment means of the present invention are occlusive and have the ability to adhere to the skin in the presence of moisture or fluids that may leak from the ostium. Made from materials that hold. By using the closure method of the invention for the adhesive layer of the second adhesive member of the above-mentioned attachment means, the moisture resistance of the entire product is improved.

Accordingly, fluid is contained by the closing adhesive layer of the second component that gradually compromises or tunnels through the adhesive layer of the first component and is applied to the user's body. Improve your time. Furthermore, by using skin-friendly non-acrylic materials for both the first and second adhesive layers, the entire product is less irritating to the skin even if the adhesive layers are closed. . The overall closure attachment means of the present invention is more extensible and more suitable for the contours of the user's body, and is therefore more comfortable for the user during use.

Relatively thick first adhesive layer 1l and relatively thin second adhesive layer 3l
blends one or more water-soluble or water-swellable hydrocolloids with polyisobutylene, or a mixture of polyisobutylene, or a mixture of one or more polyisobutylene and one or more non-acrylic elastomers. It is made as a closed adhesive layer. Other materials may include adhesive formulations such as mineral oil or tackifiers or antioxidants or cohesive enhancers, and anti-inflammatory agents or preservatives or substances that have skin healing or skin soreness properties. Possibly among pharmaceutically active substances. Suitable adhesive formulations are described by Chen, U.S. Pat. No. 3,339,546, Chen et al., U.S. Pat. et al., U.S. Pat. No. 4,551,490, and Kayas et al., U.S. Pat. No. 4,762,738. As disclosed in these publications, suitable water-soluble or water-swellable hydrocolloids include sodium carboxymethyl cellulose or pectin or gelatin or guar gum or locust bean gum or karaya gum or mixtures thereof. Suitable cohesion enhancers include water-soluble cross-linked sodium carboxymethylcellulose or water-soluble cross-linked dextran. Suitable non-acrylic elastomers include butyl rubber and styrene radical or block copolymers such as styrene-butadiene-styrene (S-B-S) and block copolymers styrene-isobrene-styrene (S-1-S). Contains.

The first adhesive member A includes a relatively thick first adhesive layer I1. By virtue of its ability to adhere to moist skin surfaces, the adhesive layer 11 has the function of fixing the device to the body and also protects the perioral skin from body fluids that leak from the ostium and do not flow into the collection bag. It has the function of sealing and protecting. Adhesive layer l1 is about 40 to about 100 mils thick, preferably about 60 to about 80 mils thick;
Most preferred is a thickness of about 70 mils. The first adhesive member A also coextends in the same space as the adhesive layer 2.
s ive) polymeric backing film l2. The backing film l2, if present, is about 1 to about 4 mils thick. Adhesive member A includes a centrally located aperture 20, which is sized to fit around the user's stoma, i.e., a lead which the user widens to fit around said stoma. It is designed to function as a hole.

The second adhesive member C includes a relatively thin adhesive layer 31 and a backing layer 32. According to a particular embodiment, the backing layer 32 comprises a thin polymeric film or a non-woven fabric. adhesive 3
l is about 8 to about 20 mils thick, preferably about 1
0 to about 12 mils thick, and the backing layer 32 is about 1 to about 4 mils thick.

Suitable materials for thin polymeric films 12 and 32 include a variety of materials commonly used in ostomy medical devices. Examples include polyolefins such as polyethylene, embossed polyethylene and polypropylene, ethylene acrylic acid, ethylene vinyl acetate, polyvinyl chloride, polyether sulfone, polyether ketone, polyether urethane, polyurethane, and the like.

Suitable nonwoven fabrics that can be used as backing layer 32 include those comprised of polyester fibers, polypropylene fibers, nylon fibers, composite olefin fibers, or cellulose fibers.

Figures 1 to 3 show two different embodiments in which the closure attachment means of the invention are utilized as the body side of a two-part coupling system.

In FIG. 1.2, the first adhesive member A comprises a relatively thick first adhesive layer l1 and a thin polymeric backing film 12 with a centrally located opening 20. In FIG. Skirt 2I and upright ribs 22 can be biased (flexible) as shown in Steele et al. U.S. Pat. No. 4,460,363 and Cilento et al. U.S. Pat. No. 4,775,374.
A male connecting member molded as a piece of polyethylene including a sealing strip 23 and a rim 24 is attached to the skirt 21.
is attached to the backing film 12 by fixing the bottom part of the film 12 to the top surface of the film 12 by ultrasonic welding, heat roll, or adhesive. The second adhesive member C is
It is dimensioned to extend outward from the rib 2 beyond the edge of the member A, and is fixed to the upper surface of the skirt 2l. This bond is adhesive in nature and can be increased by the use of heat and pressure or by a corona treating the upper surface of the skirt 21 or if necessary, as is well known in the field of plastics technology. It can be supplemented.

FIG. 3 shows an alternative structure on the body side, where the adhesive layer 3 of material C is the backing film of member A! It is attached directly to 2. In this embodiment, member C also has an opening 20 and is dimensioned to cover and extend beyond the outer edge of member A. Moreover, the skirt 2l of the male coupling member is directly secured to the polymeric backing film 32 of member C by the means described above. If layer 32 is non-woven, then the skirt is adhesively secured to layer 32.

In any of these embodiments, member A is bonded to adhesive layer l1
It will be appreciated that the polymer film I2 can be omitted in the example consisting solely of the polymer film I2.

Before use, the exposed adhesive surfaces of adhesive layers I1 and 31 are covered with a sheet of protective material, preferably a release paper coated with silicone. The embodiment of Figure 1.2 uses two separate sheets that are slit for easy removal.

As will be explained in more detail below, the embodiment shown in FIG. 3 includes adhesive layers I1 and 3! A piece of release paper sort of over both can be used.

The outer rectangular outer edges shown for the retainer C and the circular outer edges shown for sealing the skirt 21 and part A can be varied if desired. Of course, a closed or drainable ostomy bag with a channel-shaped connecting member as shown by Steele et al., U.S. Pat. It is used on the body side in Figure 3. The grooves are dimensioned to receive the ribs 22 and bias the strips 23 in a gas-tight fit. The above groove is also rim 2
4 may be included. The details of the male coupling member described above are shown for illustrative purposes only and do not form part of the present invention.

Figure L6 shows the closure attachment means of the present invention utilized as part of a one-piece ostomy device. As shown in Figure 4.5, the one-piece device 40 consists of panels 4I and 42, which are sealed around their peripheries. Panel 42 includes an aperture through which a stoma can protrude. While the sac 40 is shown as a closed end as commonly utilized by colostomy patients, it may also be shown with a clip as commonly utilized by ileostomy patients or by a urostomy patient. A similar bladder with a drainable rear portion closed by a drain valve as commonly utilized by the US Pat.

The closure attachment means shown in FIG. 4.5 consists of a first adhesive member A and a second adhesive member C. Adhesive member A is said relatively thick closure adhesive layer 11 and adhesive member C is said relatively thin closure adhesive layer 3l with a thin polymer film as backing layer 32. Adhesive layer 11 is directly bonded to adhesive layer 3l and is provided with a small hole opening 20 passing through adhesive layer 11, 3l and backing layer 32. The stoma opening 20 is smaller than the stoma opening in the bladder panel 42, and a portion of the backing layer 32 of the material C is bonded to the panel 42 around the panel opening.

The bond between the polymeric film backing layer 32 and the panel 42 can typically be made by conventional heat sealing techniques, although other types of bonds can be used, such as radio frequency welding or the use of adhesives. . In this example, part A is shown without backing layer l2. however,
Such a backing layer may be included if the adhesive layer 3I is bonded to a backing layer l2 similar to the structure shown in FIG.

In the conventional embodiment shown in FIG. 6, component A includes a relatively thick closure adhesive layer 11 and a polymeric backing film l2 with stoma openings 20. In the embodiment shown in FIG.

A portion of polymeric backing film 12 is bonded to panel 42 by techniques described above. Component C is bonded to the portion of component A that is not affixed to panel 42 by an adhesive bond between relatively thin adhesive layer 3l and polymeric backing film 12.

In this embodiment, the backing layer 32 of member C can be either a thin polymeric film or a nonwoven fabric.

In both the one-piece and two-piece embodiments described above, member C extends outwardly beyond the edge of member A, and the adhesive layer 3l contacts the user's body away from the aperture. By virtue of the closing properties of the adhesive layer 3l, the infiltration forces of the pores that form grooves or gradually spoil the adhesive layer 11 through a part thereof are absorbed by the adhesive layer 31, which Maintains adhesion even when the material is present. As a result, the use of a relatively thin adhesive layer 3l increases the useful life of the device for the user while retaining the increased benefits of flexibility and comfort. Additionally, since adhesive layer 3L is made from the same skin-friendly material as adhesive layer 11, repeated removal and attachment will be less irritating than in previous systems where layer 3I was an acrylic adhesive. .

Figure 7.8 shows the closure attachment means of the present invention made by the preferred method. This preferred method includes the closed attachment means for use as the body side of a two-part device as shown in FIG. 3 and for the construction of a one-part device as shown in FIG. 4.5. preferred for building up.

According to this improved method, the adhesive mass of the relatively thick adhesive layer 11 is built up in a conventional manner. The polyisobutylene, hydrocolloid powder and other ingredients are heated and mixed in a suitable mixer such as a Sigma blade mixer until homogeneous. This material protrudes to the desired thickness onto a sheet of silicone coated release paper. If there is a lining film layer! 2 is member A
If provided as part of the adhesive 11, a sheet of polymeric film material 12 is superimposed on the other side of the adhesive 11. If a backing layer l2 is not provided, a second sheet of release paper is superimposed on the other side of the adhesive l1. Similarly, a relatively thin adhesive layer 3l adhesive material is built up and protrudes to the desired thickness, backing layer material 32
and a release paper to form member C.

The release paper is removed from the sheet of member C.

A wafer of part A is cut into the desired shape, such as the circle shown in the figure. If the backing material A is provided with the above-mentioned backing film layer l2, the piece of release paper is removed from the adhesive layer II and the backing film layer l2
A backing film layer l2 is attached to the adhesive layer 3l of component C. If component A is not provided with backing film layer l2, both sheets of release paper are removed from adhesive layer 11 and adhesive layer 11 is removed from adhesive layer 3 of component C.
It is attached to l.

In the next step of the above method, the elongated release paper 72 is attached to the adhesive layer 3.
The release paper 7 is pasted on one corner of l.
A second sheet of 4 is pasted onto both adhesive layers I1 and 31 as well as a strip of release paper 72. This assembly is placed in a vacuum chamber and includes an adhesive layer 3l and a backing layer l2 or, if there is no backing layer l2, an adhesive layer 1! At the same time, a vacuum is applied to remove air from between the release paper 74 and the adhesive layers I+ and 31 (suction). While releasing the vacuum and reducing the differential height between surfaces 31 and I1, bonding member A is brought into intimate contact with member C to the extent that material A deforms the surface of member C. This results in a single sheet of release paper 74, both of which are firmly bonded by the adhesive surfaces.

The assembly is then removed from the vacuum chamber and the stoma opening 20 and profile cut are formed.

The contour cut can be, for example, rectangular as shown in FIG. 1 or football-shaped as shown in FIG. 4.7. Of course, the next step is to connect the closure assembly to a one-piece bladder as shown in FIG. It is coupled to formation 32 .

A release paper 74 is placed over the release paper 72 so that the user is provided with a tab that can be grasped even after the sheet 74 is removed and the device is secured in place on the body. After adhesive layers 11 and 31 are pressed against the body, the elongated release paper 72 is removed and the corners of adhesive layer 31 are pressed against the body. This structure eliminates the need to slit the release paper as is done with conventional adhesive systems.

Of course, the above closing attachment means of Figure 3.4.5 also
It can be fabricated by conventional methods in which member A is cut to shape and bonded to the sheet of member C, and a separated sheet of release paper is applied to adhesive surfaces 11 and 31, forming member C and the opening. The outer shape of 20 is cut and a hole is made.

Additionally, the assembly may be coupled to the wall of the bag as shown in FIG. 5, or a connecting member may be affixed to the lining layer 32 as shown in FIG.

As shown in FIG. 1.2, the closed attachment means of the invention are achieved by creating a superimposed adhesive layer 1l between a sheet of release paper and a polymeric backing film 12, as described above. It is configured. Moreover, the flange skirt 2I of the connecting member is attached to the polymeric backing film by ultrasonic welding or other bonding techniques. Component C is constructed by having a relatively thin adhesive layer 31 protrude through the backing layer material 32 with the other side of the adhesive layer 31 covered with a release paper.

The outside of the member C is cut into a desired rectangular shape, and the central opening is formed around the outer edge of the rib 22 of the connecting member.
be cut to fit. At the same time, a score cut is made to remove the release paper covering the adhesive layer 3l where it overlaps the flange skirt 2l. Further, the member C is attached to the flange skirt 2l, and the central leading opening 20 is attached to the member A.
A hole is drilled away from the The bond strength between the adhesive layer 3l and the skirt 2l can be increased by pre-treating the skirt 2l with corona discharge.

As shown in FIG. 6, the closure attachment means of the present invention include:
It is constructed by creating members A and C as described above. The member C is cut into the desired football shape, and the release paper of the adhesive layer 3l overlapping the backing film l2 is removed. moreover,
Member C is coupled to liner film 12 and the assembly is sealed to the bladder by heat sealing bladder panel 42 to liner film l2.

Further, the bladder panel 41 is heated and sealed to the panel 42 to complete the bladder.

The closing adhesive layers 11 and 31 are fabricated by known methods. One or both adhesive layers include about 40% by weight polyisobutylene (available as Vistanex® LMMH from Exxon) and about 60% by weight pectin and gelatin and sodium carboxymethyl cellulose. Preferably, it is a mixture with the same amount of. Alternatively, one or both adhesive layers may be made of about 8% by weight polyisobutylene [Vistanex® LM-M
H) and about 6% by weight of styrene-isoprene to styrene cobolimer [Shell Chemical Company (Shell Chemical Company)
llChemical Co. ), about 1 to 6.25% by weight of butyl rubber (Exxon grade 065);
2.7 5% by weight tackifier [Hercules
Chemical Company (Hercules Chemi)
cal Co. Pentaline (P en
talynX registered trademark)H] and about 11
．． Preferably, it is a mixture of 50% by weight mineral oil, about 0.50% by weight of antioxidant, about 45% by weight of a mixture of equal amounts of vectin, gelatin and sodium carboxymethylcellulose. Backing layer 32 and polymer film I
If present, they are both preferably 1 mil thick embossed low density polyethylene films.

Although the closure attachment means of the present invention has been described as part of a one- or two-part system, the closure attachment means such as that shown in FIG.
barrier dressing) or skin barrier (s
can be used as a kin barrier). Additionally, the user may adhesively secure the bladder to the surface 32 of the backing layer.

4. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view showing the closure attachment means of the present invention as a skin barrier in a two-part canal system; FIG. An enlarged front view of an enlarged detailed composite skin barrier; FIG. 3 is a similar enlargement to FIG. 2 of another embodiment of the use of the closure attachment means of the present invention as a skin barrier in a two-part slimming system. 4 is a front view showing the closure attachment means of the present invention used as part of a one-piece slimming bag; FIG. 5 is a side view along line 5; FIG. 6 is a side view similar to FIG. 5 illustrating another method of utilizing the closure attachment means of the present invention for a one-piece surgical bladder; FIG. 7 is a side view taken along line 5; 8-8 of FIG. 7.
It is a side view along a line.

! I... First adhesive layer, 12... Lining film, 20
...Opening, 21...Skirt, 22...Rib, 2
3... Strip, 24... Rim, 31... Relatively thin adhesive layer, 32... Lining layer, 40... Bag, 41
．． 42... Panel, 7 2.7 4... Release paper.

Patent applicant: E.R. Squibb & Sons, Incorporated, agent: Patent attorney: Aoyama Aoyama and two others (;.
/ II (;.5 FI6. 6 HG.θ 51 jz Continuation of 1st page @ Inventor @ From Thomas A. Iliades Honor Letter F・Drive Guo Ban United States Pennsylvania, Yardley, South Dead Drive No. 19

Claims (27)

[Claims] (1) a first adhesive member having a first closure adhesive layer from about 40 to about 100 mils thick; a second adhesive member having a second closure adhesive layer and a backing layer from about 8 to about 20 mils thick; and the second adhesive member extends beyond the first adhesive member, so that the second adhesive layer contacts the skin beyond a portion where the first adhesive member contacts the skin. A closure bandage featuring: 2. The occlusive bandage of claim 1, wherein the backing layer of the second adhesive member is a nonwoven fabric or a thin polymeric film having a thickness of about 1 to about 4 mils. (3) the first adhesive member comprises a thin polymeric backing film from about 1 to about 4 mils thick attached to the first closure adhesive layer, and the second closure adhesive layer is attached to the first closure adhesive layer; 2. The occlusive bandage of claim 1, wherein the bandage is affixed directly to opposite sides of the polymeric backing film of the member. (4) Both closing adhesive layers are composed of one or more water-soluble or water-swellable hydrocolloids and polyisobutylene, or a mixture of polyisobutylene, or one or more polyisobutylene and one or more non-acrylic 2. The occlusive dressing of claim 1, wherein the occlusive dressing is made from a mixture comprising: 5. The occlusive dressing of claim 4, wherein the one or both occlusive adhesive layers also include one or more components selected from mineral oil, tackifiers, and cohesive enhancers. (6) one or both closing adhesive layers include about 40% by weight polyisobutylene, about 20% by weight gelatin, about 20% by weight polyisobutylene;
5. The occlusive bandage of claim 4 having, by weight, pectin and about 20 weight percent sodium carboxymethyl cellulose. (7) One or both closing adhesive layers include about 8% by weight polyisobutylene and about 6% by weight styrene-isoprene-
a copolymer of styrene, about 16.25% by weight butyl rubber, about 12.75% by weight tackifier; about 11.
6. The occlusive dressing of claim 5 having 5% by weight mineral oil, about 0.5% by weight antioxidant, and about 45% by weight a mixture of equal parts pectin, gelatin and sodium carboxymethyl cellulose. . (8) an elongated release paper is affixed to one corner of said second adhesive layer, and a sheet of release paper is a second adhesive layer having said first adhesive layer and said elongated release paper at said corner; 2. The occlusive bandage of claim 1, wherein said bandage includes a tab that can be grasped by a user even when said sheet of release paper is removed and said bandage is applied to a body. (9) a first step of blending the components of the first closure adhesive layer to form a homogeneous material; and a step of extruding the first closure adhesive material onto a sheet of release paper to a thickness of about 40 to about 100 mils. a third step of overlapping a polymeric backing film with a thickness of about 1 to about 4 mils on opposite sides of the first adhesive layer to form a first closed adhesive member, and to form a homogeneous material. a fourth step of blending the components of a second closure adhesive layer; a fifth step of extruding the second closure adhesive material onto a sheet of release paper to a thickness of about 8 to about 20 mils; and a second closure adhesive member. a sixth step of overlapping a backing layer on opposite sides of the second adhesive layer to form a backing layer; a sixth step of cutting the second adhesive member into a desired shape; a seventh step of removing the release paper sheet from both adhesive layers; and a seventh step of cutting the second adhesive member into a desired shape;
an eighth step of affixing the backing film of the adhesive member to a second adhesive layer; and affixing an elongated release paper to the exposed corner of the second adhesive layer, and a second adhesive layer having the first adhesive layer and the elongated release paper. a ninth step of placing a sheet of release paper on top of the adhesive layer, and placing a sheet of release paper assembled in the ninth step in a vacuum chamber, and placing a sheet of release paper on top of the adhesive layer and between the first and second adhesive members and with both adhesive layers. a tenth step of removing air from between and between the sheets of release paper, and releasing the vacuum to bring the first and second adhesive members into intimate contact, firmly bonding the sheets of release paper at both adhesive surfaces; 11. A method for assembling an occlusive bandage, comprising: an eleventh step. (10) a first step of blending the components of the first closure adhesive layer to form a homogeneous material; and a step of extruding the first closure adhesive material onto a sheet of release paper to a thickness of about 40 to about 100 mils. a third step of superimposing a second sheet of release paper on opposite sides of the first adhesive layer; a fourth step of blending the components of the second closed adhesive layer to form a homogeneous material; and peeling. a fifth step of extruding said second closure adhesive material over a sheet of paper to a thickness of about 8 to about 20 mils; and a backing layer on an opposite side of said second adhesive layer to form a second closure adhesive member. and cutting the first adhesive layer in the third step and the second adhesive member in the sixth step into a desired shape so that the first adhesive layer is smaller than the second adhesive member. a seventh step of removing the two sheets of release paper from the first adhesive layer, removing the sheet of release paper from the second adhesive layer, and attaching the first adhesive layer to the second adhesive layer; an eighth step; affixing a strip of release paper to the exposed corner of the second adhesive layer; and a ninth step of placing a sheet of release paper over the first adhesive layer and the second adhesive layer having the strip of release paper; a tenth step of placing the assembly of the ninth step in a vacuum chamber and removing air from between the first and second adhesive layers and between both adhesive layers and the sheet of release paper; and an eleventh step of releasing the vacuum to bring the first and second adhesive members into close contact and firmly bonding the sheet of release paper on both adhesive surfaces. How to assemble an occlusive dressing. (11) a first adhesive member having a first closing adhesive layer having a thickness of about 40 to about 100 mils and a thin polymeric backing film having a thickness of about 1 to about 4 mils; and an upright rib and flange. a connecting member having a diameter of about 8 to
a second adhesive member having a second closure adhesive layer about 20 mils thick and a backing layer, the flange being secured to the backing film of the first adhesive member, and the second adhesive layer A body of a two-part fistula system, wherein the second adhesive member is secured to opposite sides of a flange of a member, the second adhesive member extending beyond the edge of the flange and the first adhesive member. Closed mounting means for use as a side. 12. The closure attachment means of claim 11, wherein the backing layer of the second adhesive member is a nonwoven fabric or a thin polymeric film having a thickness of about 1 to about 4 mils. (13) Both closing adhesive layers are composed of one or more water-soluble or water-swellable hydrocolloids and polyisobutylene, or a mixture of polyisobutylene, or one or more polyisobutylene and one or more non-acrylic 12. A closure attachment means according to claim 11, wherein the closure attachment means is made from a mixture comprising: a mixture with a base elastomer; 14. The closure attachment means of claim 13, wherein the one or both closure adhesive layers also include one or more components selected from mineral oil, tackifiers, and cohesive enhancers. (15) a first adhesive member having a first closing adhesive layer with a thickness of about 40 to about 100 mils, and a second adhesive member having a second closing adhesive layer and a backing layer with a thickness of about 8 to about 20 mils; a connecting member having an upright rib and a flange, the second adhesive layer being secured to the first adhesive member and extending beyond an edge of the first adhesive member; Closing attachment means for use as the body side of a two-part fistula system, characterized in that the second adhesive member is secured to the backing film. 16. The closure attachment means of claim 15, wherein the backing layer of the second adhesive member is a nonwoven fabric or a thin polymeric film having a thickness of about 1 to about 4 mils. (17) the first adhesive member has a thin polymeric backing film coextensive with the first closure adhesive layer, and the polymeric backing film of the first adhesive member is secured to the second closure adhesive layer; 16. A closure attachment means according to claim 15. (18) Both closing adhesive layers are composed of one or more water-soluble or water-swellable hydrocolloids and polyisobutylene, or a mixture of polyisobutylene, or one or more polyisobutylene and one or more non-acrylic 16. Closed attachment means as claimed in claim 15, wherein the closure means is made from a mixture comprising a mixture of elastomers and elastomers. 19. The closure attachment means of claim 15, wherein the one or both closure adhesive layers also include one or more components selected from mineral oil, tackifiers, and cohesive enhancers. (20) a one-piece fistula pouch comprising anterior and posterior pouch panels connected along the outer edge and closure attachment means, the front panel having an opening adapted to enter into the pouch for a stoma; and the closure attachment means comprises a first adhesive member having a first closure adhesive layer having a thickness of about 40 to about 100 mils, a second closure adhesive layer having a thickness of about 8 to about 20 mils, and a second closure adhesive layer having a thickness of about 8 to about 20 mils. a second adhesive member having a thin polymeric backing film of ~4 mil thickness, the second adhesive layer being secured to the first adhesive member and extending beyond the edge of the first adhesive member. The lining film of the second adhesive member extends and is secured to the anterior capsule panel around the opening of the stoma in the anterior panel. (21) the first adhesive member of the closure attachment means has a polymeric backing film coextensive with the first closure adhesive layer; 21. The one-piece fistula bladder of claim 20, adapted to be secured to an adhesive layer. (22) Both closure adhesive layers of said closure attachment means are comprised of one or more water-soluble or water-swellable hydrocolloids and polyisobutylene, or a mixture of polyisobutylene, or one or more polyisobutylene and one or more polyisobutylene. 22. The one-piece fistula bladder of claim 21, wherein the one-piece fistula bladder is made from a mixture comprising: a mixture with a non-acrylic elastomer; 23. The closure adhesive layer of one or both of the closure attachment means also includes one or more components selected from mineral oil, tackifiers, and cohesive enhancers.
For the one-part fistula procedure described in . Sac. (24) a one-piece fistula pouch comprising anterior and posterior pouch panels connected along the outer edge and closure attachment means, the front panel having an opening adapted to enter into the pouch for a stoma; the closure attachment means having a first adhesive member having a first closure adhesive layer having a thickness of about 40 to about 100 mils and a thin polymeric backing film having a thickness of about 1 to about 4 mils; a second closure adhesive layer and a backing film having a thickness of 8 to about 20 mils;
an adhesive member, wherein the backing film of the first adhesive member is sealed to the anterior capsular panel around the stoma opening in the anterior panel, and an outer periphery of the first adhesive member is attached to the anterior capsular panel. the second adhesive layer is fixed to the outer periphery of the backing film of the first adhesive member, and the second adhesive member extends beyond the edge of the first adhesive member; A fistula sac featuring: 25. The one-piece fistula bladder of claim 24, wherein the backing layer of the second adhesive member is a nonwoven fabric or a thin polymeric film having a thickness of about 1 to about 4 mils. (26) Both closure adhesive layers of said closure attachment means are comprised of one or more water-soluble or water-swellable hydrocolloids and polyisobutylene, or a mixture of polyisobutylene, or one or more polyisobutylene and one or more polyisobutylene. 25. The one-piece fistula bladder of claim 24, wherein the bladder is made from a mixture having a mixture with a non-acrylic elastomer. 27. The closure adhesive layer of one or both of the closure attachment means also includes one or more components selected from mineral oil, tackifiers, and cohesive enhancers.
A one-part fistula sac as described in .